Evidence map›Paper›PMID 35656777›Full record

ArticleFuture oncology (London, England)2022

Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: a patient and caregiver perspective and plain language summary of the ARASENS trial.

Matthew R Smith, Maha Hussain, Fred Saad, Karim Fizazi, Cora N Sternberg, David Crawford, Jan Manarite, David Muslin, Thomas Farrington, Bertrand Tombal

Registry-linked trialOpen access · hybridAbstract readCommentPatient Education Handout
PubMed Publisher
In one paragraph

Article in Future oncology (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02799602 (A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02799602 phase3completednot on this map

A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

TypeinterventionalSponsorBayerRan2016 to 2023Enrolled1,306ConditionsMetastatic Hormone-sensitive Prostate CancerArmsBAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 5 countries.

Matthew R SmithMassachusetts General Hospital Cancer Center, Boston, MA.
Maha HussainNorthwestern University, Feinberg School of Medicine, Chicago, IL.
Fred SaadUniversity of Montreal Hospital Center, Montreal, Quebec, Canada.
Karim FizaziInstitut Gustave Roussy, University of Paris-Saclay, Villejuif, France.
Cora N SternbergEnglander Institute for Precision Medicine, Weill Cornell Department of Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York, NY.
David CrawfordUC San Diego School of Medicine, San Diego, CA.
Jan ManariteCaregiver Author.
David MuslinPatient Author.
Thomas FarringtonPatient Author.
Bertrand TombalDivision of Urology, IREC, Cliniques Universitaires Saint Luc, UCLouvain, Brussels, Belgium.
National Patient Safety Foundation · USCenter for Cancer Research · USCliniques Universitaires Saint-Luc · BEMontreal General Hospital · CANorthwestern University · USPresbyterian Hospital · USUC San Diego Health System · USUniversité Paris-Saclay · FR

Funding

Bayer
6 · The paper itself

Abstract

WHAT IS THIS SUMMARY ABOUT?: This is a summary of a publication about the ARASENS trial, which was published in the WHAT WERE THE RESULTS?: The trial results showed that combining darolutamide with ADT and docetaxel increased the chance of survival and lowered the risk of death by 32.5% compared to combining ADT and docetaxel with placebo instead. Compared to patients who received the placebo, patients who received darolutamide had a delay in: their cancer becoming castration-resistant worsening pain having cancer-related bone fractures or related symptoms needing additional therapies for cancer The percentage of trial patients who had medical problems during the trial, also called adverse events, was similar between trial patients who received darolutamide and those who received the placebo. WHAT DO THE RESULTS OF THE STUDY MEAN?: Combining darolutamide with ADT and docetaxel helped treat trial patients with mHSPC better than placebo with ADT and docetaxel. Darolutamide in combination with ADT and docetaxel could be a treatment option for patients with mHSPC. Patients should always talk to their doctors and nurses before making any decisions about their treatment. This summary also includes perspectives on the ARASENS trial and prostate cancer from 3 members of the patient community. ClinicalTrials.gov NCT number: NCT02799602.

Indexed as

Androgen AntagonistsProstatic NeoplasmsCaregiversDocetaxelHormonesHumansLanguageMalePyrazolesAndrogen AntagonistsdarolutamideDocetaxelHormonesPyrazolesDarolutamideDrug developmentLay summaryMetastatic hormone-sensitive prostate cancerNovel therapyOverall survivalPlain language summarySafetyUrological/prostate

Identifiers

PMID35656777
OpenAlexW4281845935

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.